by Elizabeth E. Hogue, Esq. | Feb 28, 2024 | Clinical
by Elizabeth E Hogue, Esq.,
After a hospitalized patient suffered a severe choking incident and was placed on life support, his family faced a difficult decision in response to a telephone call from the hospital. They were asked if they wanted to remove life support. The family told the hospital that they did. The hospital subsequently removed life support and the patient passed away. Then came something that no one expected: the patient who was allegedly deceased telephoned his family!
The mix-up started with a call to 911. Medics responded to a call about a choking incident involving a piece of steak. The man who choked was not breathing and was unconscious when they arrived. Somewhere along the line, the patient was misidentified and treated as another patient.
Parents that were called to make life-ending decision for wrong person
The family of the living patient called non-emergency police services to notify authorities that the patient was not, in fact, deceased. The Medical Examiner’s Office retrieved the body from the funeral home, conducted an external examination, and used fingerprints to confirm the deceased patient’s identity. In a gross understatement, a member of the patient’s family said, “Somebody messed up.”
Although the consequences of decision-making by so-called “substitute decision-makers” are not usually so dire, the fact remains that providers and practitioners are obligated to seek informed consent from those authorized to give it when patients cannot consent for themselves.
Here are some questions that providers frequently ask about substitute consent:
If patients cannot consent, who can consent on their behalf?
The answer to this question varies depending on the laws of the state in which patients reside. Consent may be provided on behalf of incapacitated adults by:
- An attorney-in-fact, i.e., someone who has authority under a durable power of attorney
- Individuals authorized to consent under state substitute consent statutes
- Guardians or conservators of the person
- Courts
How old must patients be in order to be able to give valid informed consent?
Generally, patients must have reached the age of adulthood before they can give informed consent. The age at which individuals become adults, as opposed to minors, is defined by state law, so the age of adulthood varies from state to state. Practitioners who provide services in multiple states must take this fact into account when obtaining consent. When minors are unable to consent, the general rule is that their parents may give substitute consent on their behalf.
Are there any exceptions to this rule?
Yes. Patients who are not adults, but who seek certain types of care, such as treatment for sexually transmitted diseases, or who are “emancipated” may consent on their own behalf depending on the law in the state in which the patient resides.
What evidence of valid informed consent should practitioners obtain?
Providers may:
- Ask patients to sign a consent form
- Document consent in patients’ charts with or without patients’ signatures on the documentation
- Record consent
- Video the consent process
- Give patients a short written quiz on the material provided and, if patients answer the questions correctly, put a copy in patients’ charts
- Utilize any other credible forms of evidence of consent
The above case certainly illustrates the need to make sure that consent is obtained from appropriate givers of substitute consent and to document their authority.
©2024 Elizabeth E. Hogue, Esq. All rights reserved.
No portion of this material may be reproduced in any form without the advance written permission of the author.
by Elizabeth E. Hogue, Esq. | Feb 21, 2024 | Admin
By Elizabeth E. Hogue, Esq.
Case managers/discharge planners continue to come under fire from fraud enforcers for violations of the federal anti-kickback statute. This statute generally prohibits anyone from either offering to give or actually giving anything to anyone in order to induce referrals. Case managers/discharge planners who violate the anti-kickback statute may be subject to criminal prosecution that could result in prison sentences, among other consequences.
A U.S. District Judge in California sentenced an owner of a post-acute provider to eighteen months in prison for one count of conspiracy to commit health care fraud and one count of conspiracy to pay and receive health care kickbacks. From July of 2015 through April of 2019 the provider paid and directed others to pay kickbacks to multiple case managers/discharge planners for referrals of Medicare patients, including employees of health care facilities and employees’ spouses. Recipients of the kickbacks included a discharge planner/case manager at a hospital, and discharge planners at skilled nursing and assisted living facilities.
Payments of kickbacks resulted in over eight thousand claims to Medicare for patients referred to the provider. Medicare paid the provider at least two million dollars for services provided to patients referred in exchange for kickbacks. Because the provider obtained patient referrals by paying kickbacks, the provider should have not received any Medicare reimbursement. The discharge planners/case managers who received kickbacks from the provider also pled guilty and will be sentenced soon.
The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), the primary enforcer of fraud and abuse prohibitions, says that discharge planners/case managers and social workers cannot accept the following from providers who want referrals:
- Cash
- Cash equivalents, such as gift cards or gift certificates
- Non-cash items of more than nominal value
- Free discharge planning services that case managers/discharge planners and social workers are obligated to provide
Discharge planners/case managers and social workers provide extremely important services that are valued by many patients and their families, but their credibility and trustworthiness is destroyed when they make referrals based on kickbacks received.
A word to managers and all the way up the chain of command to CEOs: whether or not you know when case managers/discharge planners accept kickbacks, the OIG may also hold you responsible.
You may be responsible if you knew or should have known. The OIG has made it clear that your job is to monitor and to be vigilant. A good starting point is to put in place a policy and procedure requiring discharge planners/case managers to report in writing anything received from post-acute providers. Even better, how about a policy and procedure that prohibits all gifts?
Now a word to post-acute marketers: do not give kickbacks to discharge planners/case managers and social workers. It is simply untrue that you must give kickbacks in order to get referrals. The proverbial bottom line is: Do you like the color orange? Is an orange prison uniform your preferred fashion statement? Please stop now!
Reprinted with permission from ©2024 Elizabeth E. Hogue, Esq. All rights reserved.
No portion of this material may be reproduced in any form without the advance written permission of the author.
by Elizabeth E. Hogue, Esq. | Feb 14, 2024 | Admin
by Elizabeth E. Hogue, Esq.
Two former Amedisys employees claim that they were fired in retaliation for alerting management to possible violations of the federal False Claims Act. They then filed a whistleblower, or qui tam, lawsuit [Pilat v. Amedisys, Inc., No. 23-566 (2d Cir. Jan. 17, 2024)]. In their whistleblower suit, the employees claim that they complained internally to supervisors about suspected fraudulent practices and refused to engage in such practices.
The employees, for example, recommended against recertifying patients, but supervisors overruled the recommendations and recertified patients again. One of the employees then refused instructions from his supervisors to recertify the patient yet again. The employee said that the patient was completely independent and it would be “unethical” to do so.
The employees also expressed concern to supervisors about the inability of nurses and therapists to keep up with a large volume of patients. One employee said he had to schedule visits for three times as many patients as was safe. The employees explained that many patients were seen for only a few minutes rather than an appropriate amount of time. The employees said that one nurse was assigned to make eighty-six visits during one week and another was assigned to make seventy-eight visits. Amedisys billed for the visits anyway.
In addition, former employees identified multiple specific instances in which clinicians were instructed to document false information about patients. The false documentation was then used to support treatments for which patients did not qualify or to recommend unnecessary treatments. Supervisors, for example, instructed employees to fraudulently document that a fifty-year-old man whom an employee was treating was not independent and needed assistance to climb stairs. The patient did not need such assistance.
The employees further claimed that a female patient in her late fifties with early onset Parkinson’s disease received services during an episode of care. The severity of her condition was overstated in order to continue treatment.
Perhaps the most vivid example provided by the employees involved a female patient who was approximately seventy years old who had a neurological disorder that limited her mobility. The patient’s condition did not prevent her from leaving home or from driving. Supervisors repeatedly overruled employees’ recommendations to reduce visits even though she was completely independent and it would be “unethical” to provide more intensive treatment. The employees were also told not to document a leg injury that the patient suffered in a car accident because documentation of the accident would make it clear that she was not actually homebound and that she did not meet eligibility requirements of the Medicare Program.
Providers must take seriously employees’ concerns regarding possible fraudulent and abusive practices. Most whistleblowers take their concerns to their employers first. It is only when employers ignore their concerns or, even worse, retaliate against employees for raising issues in the first place, that employees turn to outside enforcers for assistance in pursuing their concerns. Whether or not the allegations of employees are valid, providers must take them seriously. Thorough investigations are required in order to demonstrate to employees that there is no problem or that the problem has been corrected.
Although this case involves home health services, the message applies to all types of providers. The message from this case and numerous other lawsuits is clear: Don’t shoot the proverbial messenger who brings information about possible fraud and abuse violations. There is a very heavy price to be paid.
©2024 Elizabeth E. Hogue, Esq. All rights reserved.
No portion of this material may be reproduced in any form without the advance written permission of the author.
by Elizabeth E. Hogue, Esq. | Feb 7, 2024 | Admin, Regulatory
by Elizabeth E. Hogue, Esq.
A caregiver in Wyoming who is charged with causing the death of her mother has been jailed based on allegations that she committed aggravated assault and battery; deliberate abuse of a vulnerable adult; and intentionally and maliciously killing another human being, commonly known as 2nd degree murder. The defendant, Edwina Leman, cared for her mother, Mary Davis, beginning in June of 2022. At the time of the events described below, Davis was a hospice patient.
On December 28, 2023, Leman’s son heard her yelling at her mother. At some point, he heard an audible “thump” and Davis began to scream. The son then entered the bathroom and found Leman pulling roughly on her mother’s leg, even though Davis was screaming that it hurt. According to Leman’s son, Leman then told her mother “not to be dramatic” and called her “Marygina,” a derogatory name the caregiver had previously called Davis on multiple occasions.
Leman claimed that she was removing her mother’s clothing “more forcibly than necessary when she fell.” She also said that Davis became very frail and fragile during the time the patient lived with her. Leman admitted that she had a temper and had “thumped or swatted” her mother on the head at various times in the past.
Leman’s husband and son said that they saw the caregiver engage in a pattern of physical and verbal abuse toward Davis. The caregiver screamed at her mother and sometimes called her names. Leman’s husband said he saw his wife hit the patient on the head and push her while she was walking with her walker. Leman said that she also pushed Davis when she was not using her walker, which caused her to fall to the ground. The coroner’s report said that Davis died of complications of a displaced fracture of her femur.
A sad story indeed! We read it and weep!
This case is a reminder for all types of providers who render services to patients in their homes to be alert to any signs of abuse or neglect, and to take action to protect patients who are subject to abuse or neglect. Action by providers should include reports to adult protective services. Providers may respond to this recommendation by saying that adult protective services rarely takes action based on their reports. Providers must remember, however, that reports to adult protective services are required in many states. In addition, it is important to establish a record of abuse and neglect even if authorities do not take action. Better to err, if necessary, on the side of protecting patients.
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©2024 Elizabeth E. Hogue, Esq. All rights reserved. No portion of this material may be reproduced in any form without the advance written permission of the author.
©2024 by The Rowan Report, Peoria, AZ. All rights reserved. This article originally appeared in Healthcare at Home: The Rowan Report.homecaretechreport.com Reprinted by permission. One copy may be printed for personal use: further reproduction by permission only. editor@homecaretechreport.com
by Elizabeth E. Hogue, Esq. | Jan 31, 2024 | Admin, Regulatory
by Elizabeth E Hogue, Esq.
Providers may have heard or read about the importance of Fraud and Abuse Compliance Plans in their organizations. Despite the wealth of available information about Compliance Plans, many providers continue to express uncertainty about their value. Here are some of the questions providers commonly ask about Compliance Plans:
Why should we have a Fraud and Abuse Compliance Plan?
First, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services has clearly stated that, consistent with the Affordable Care Act (ACA) as described below, all providers are now expected to have current Compliance Plans that are fully implemented.
As a practical matter, when providers establish and maintain Compliance Plans, it clearly discourages regulators from pursuing allegations of fraud and abuse violations.
Technically speaking, the Federal Sentencing Guidelines make it clear that establishment and implementation of Compliance Plans is considered to be a mitigating factor. That is, if accusations of criminal conduct are made, the consequences may be substantially less severe because of a properly implemented Compliance Plan.
In addition, providers with Compliance Plans are more likely to avoid fraud and abuse. This is because Plans routinely establish an obligation on the part of every employee to report possible instances of fraud and abuse, and Plans include training for all employees.
Compliance Plans may help to prevent qui tam or so-called “whistleblower” lawsuits by private individuals, rather than by government enforcers, who believe that they have identified instances of fraud and abuse. There are significant incentives to bring these legal actions since whistleblowers receive a share of monies recovered because of their efforts. Some whistleblowers have received millions of dollars. Compliance Plans make it clear that employees have an obligation to bring any potential fraud and abuse issues to the attention of their employers first. Compliance Plans provide a clear path to resolve fraud and abuse issues internally.
In addition, the federal Affordable Care Act (ACA) requires providers to have Compliance Plans. In short, it’s the law!
Finally, the Deficit Reduction Act (DRA) requires providers who receive more than $5 million in monies from state Medicaid Programs per year to implement policies and procedures, provide education to employees, and put information in their employee handbooks about fraud and abuse compliance. These requirements can be met through implementation of Fraud and Abuse Compliance Plans.
We don’t receive reimbursement from the Medicare or Medicaid Programs. Do we still need a Compliance Plan?
Statutes and regulations governing fraud and abuse also apply to providers who receive payments from any federal and state healthcare programs, including Medicaid, Medicaid waiver and other federal and state health care programs, such as TriCare and the VA. Many private insurers have followed the federal government’s lead in terms of fraud and abuse enforcement. Therefore, providers that don’t receive reimbursement from the Medicare Program must have compliance plans, too.
We hear that the OIG of the U.S. Department for Health and Human Services has provided guidance for various segments of the healthcare industry regarding Compliance Plans.
- Specifically, the OIG has already published guidance for clinical laboratories, hospitals, home health agencies, hospices, physicians’ practices, third-party billing companies, and home medical equipment companies. Should we just use the model guidance that is applicable to us?
The answer is, “No!” Guidance from the OIG is not a model Compliance Plan. Guidance from the OIG consists of general guidelines and does not constitute valid Compliance Plans. In addition, the OIG has made it clear that Plans must be customized for each organization.
We have read that, before implementing Compliance Plans, providers must conduct expensive internal audits that can take many months to complete. Is this true?
While beginning the compliance process with an extensive internal audit is certainly one way to proceed, it is not the only viable way to work toward compliance. It is equally valid to begin with Compliance Plans that are customized for the organization and include training for all employees about fraud and abuse, and Compliance Plans. Then all staff members can subsequently participate in internal compliance activities, including audits, with a process in place to handle any issues that arise as a result of the audits.
We have all sorts of policies and procedures in our organization. Why do we need something else called a Compliance Plan?
Compliance Plans are specific types of documents that routinely address fraud and abuse issues that providers do not usually cover in internal policies and procedures. In addition, providers may not gain benefits under the Federal Sentencing Guidelines described in paragraph one (1) above if there is no formal document called a Compliance Plan.
We just spent a lot of money to become accredited or reaccredited. Doesn’t certification mean that we are in compliance?
On the contrary, Compliance Plans appropriately address potential fraud and abuse issues. They also include mechanisms for helping to ensure compliance, such as processes for identification and correction of potential problems that are not addressed during the certification process. In other words, organizations may be accredited, but fail to meet applicable compliance standards for fraud and abuse.
Will the fact that our organization has a Compliance Plan make any difference regarding the outcome of fraud and abuse investigations and the imposition of Corporate Integrity Agreements (CIA’s)?
Yes, it may make a considerable difference, based on statements from the OIG. If providers have Compliance Plans in place during investigations that are current and fully implemented, the OIG may be less aggressive in pursuing potential violations. Enforcers are likely to ask for information about Compliance Plans and related policies and procedures. Enforcers are now also likely to ask providers to show them how much money they have spent on fraud and abuse compliance activities!
When the OIG discovers problems with fraud and abuse in organizations, providers are usually asked to develop and implement a Corporate Integrity Agreement (CIA). The OIG often requires CIA’s to include a process for stringent monitoring by the OIG on a continuous basis. These monitoring activities can be extremely burdensome to providers in terms of both time and money. Providers with valid Compliance Plans may not be asked to develop and implement CIA’s.
Now is the time for all providers to recognize and act upon the need to establish and maintain Compliance Plans. “Working on it” is no longer good enough.
©2024 Elizabeth E. Hogue, Esq. All rights reserved.
No portion of this material may be reproduced in any form without the advance written permission of the author.
by Elizabeth E. Hogue, Esq. | Nov 8, 2023 | Clinical
Untitled Document
by Elizabeth E. Hogue, Esq.
Joyce Grayson, a home health nurse for Elara Caring, was murdered on October 28, 2023, in the home of a patient where she was providing services. Ms. Grayson was reported missing by a family member to the local police department. The family member was also able to track her last location to the home of a patient she was scheduled to visit at 8:00 a.m. on the day of her death. The patient resided at a halfway house for convicted sex offenders. Police have not yet formally identified a suspect in Ms. Grayson’s death.
This horrible news reminds of steps that staff members and providers can take to protect their staff members:
- Staff members should be sure of the locations of patients’ homes and have accurate directions. · Employees should contact their supervisors in the event of threatening circumstances.
- During visits, employees should remain alert and watch for signs of possible violence; such as verbal expressions of anger and frustration, threatening gestures, signs of drug or alcohol use, or the presence of weapons.
- When employees are verbally abused in patients’ homes, they should ask the speaker(s) to stop. If verbal abuse continues, caregivers should leave patients’ homes and notify their supervisors that they have done so. · If possible, caregivers should identify more than one exit from patients’ homes and keep a clear path to at least one of them.
- All employees should read or reread The Gift of Fear by Gavin de Becker and take action when their instincts tell them that they should be fearful. · Management should develop a written policy of “zero tolerance” for all incidents of violence, regardless of source. The policy should include animals! The policy must require employees and contractors to report and document all incidents of violence, no matter how minor. Emphasis should be placed on both reporting and documenting. Employees must provide as much detail as possible. The policy should also include “zero tolerance” for visible weapons when caregivers are present in patients’ homes. Caregivers must be required to report the presence of visible weapons.
- Agencies should develop quality indicators that improve efforts to protect staff. Indicators in quality and safety standards should include patient assault and other instances of violence or threatened violence. The results of these indicators should result in violence prevention plans and training programs in de-escalation of violence.
- Data systems should be strengthened to monitor the exposure of staff members to aggression. More resources should be invested in measuring aggressive events and specific factors that resulted in exposure, such as patient type.
- Ongoing education should be provided to protect staff. Education should focus on intentional actions that staff members must take to recognize, document, and counter threatened or actual violence.
The Connecticut General Assembly recently passed a law to increase protection for healthcare workers that does not include home care providers. Now lawmakers are calling for extension of the legislation to include home healthcare staff. Martin Looney, President Pro Tempore of the Connecticut State Senate told the CT Mirror: “More and more care is going to be provided in a home setting, which is generally a good thing. But if that is true, we need to make sure that the people who are providing that care are safe.”
Amen to that, Mr. Looney! Let’s get to it!
©2023 Elizabeth E. Hogue, Esq. All rights reserved. No portion of this material may be reproduced in any form without the advance written permission of the author.
by Elizabeth E. Hogue, Esq. | Jul 12, 2023 | CMS, Regulatory
by Elizabeth Hogue, Esq.
For providers to be liable under the federal False Claims Act, enforcers must prove that they knowingly submitted false claims. The U.S. Supreme Court recently issued an opinion in United States ex rel. Schutte v. SuperValu, Inc. [No. 21-1326 (U.S. June 1, 2023)], which defines what “knowingly” means. The Court decided that providers act knowingly depending on their “culpable state of mind” when they submitted alleged false claims; not what providers may have thought after submitting them. The requirement to prove knowledge, or “scienter,” said the Court, refers to providers’ knowledge and subjective beliefs; not to what objectively reasonable persons may have known or believed.
On June 30, 2023, the U.S. Supreme Court issued orders that revive two whistleblower lawsuits based on the opinion described above. Specifically citing the above decision, the Court granted whistleblower Troy Olbausen’s request to hear his case. The Court then vacated an Eleventh Circuit decision that dismissed Olhausen’s whistleblower lawsuit.
The Eleventh Circuit previously dismissed Olhausen’s suit against Arriva Medical because he could not prove that the defendants had knowledge of their submission of false claims in view of their objectively reasonable interpretation of the Medicare rules in question. The Supreme Court sent the case back to the Eleventh Circuit for further consideration based on its decision in Schuttte v. SuperValu, above [Olhausen v. Arriva Med., LLC, No. 22-374 (U.D. June 30, 2023)].
Likewise, on June 30, 2023, the Supreme Court sent a case back to the Fourth Circuit for further consideration in light of the Schutte case.
These actions make it clear that the new standard set by the Supreme Court in the Schutte case will make a difference in cases based on the federal False Claims Act. The Court said in the Schutte case:
“Both the text and the common law also point to what the defendant thought when submitting the false claim – not what the defendant may have thought after submitting it…As such, the focus is not, as respondents would have it, on post hoc interpretations that might have rendered their claims accurate. It is instead on what the defendant knew when presenting the claims…Culpability is generally measured against the knowledge of the actor at the time of the challenged conduct.”
The Court also said:
“Under the FCA, petitioners may establish scienter by showing that respondents:
- actually knew that their reported prices were not their ‘usual and customary’ prices when they reported those prices;
- were aware of a substantial risk that their higher, retail prices were not their ‘usual and customary’ prices and intentionally avoided learning whether their reports were accurate, or
- were aware of such a substantial and unjustifiable risk but submitted the claims anyway…
If petitioners can make that showing, then it does not matter whether some other, objectively reasonable interpretation of ‘usual and customary’ would point to respondents’ higher prices. For scienter, it is enough if respondents believed that their claims were not accurate.”
Proving that providers submitted false claims just got tougher for enforcers.
See Ms. Hogue’s earlier report on this SCOTUS case in our June 7 edition: homecaretechreport.com/article/3587
©2023 Elizabeth E. Hogue, Esq. All rights reserved. No portion of this material may be reproduced in any form without the advance written permission of the author.
©2023 by Rowan Consulting Associates, Inc., Colorado Springs, CO. All rights reserved. This article originally appeared in Home Care Technology: The Rowan Report. homecaretechreport.com One copy may be printed for personal use; further reproduction by permission only. editor@homecaretechreport.com
